JP7374185B2 - Tissue care equipment and usage - Google Patents

Description

Cross-reference of related applications
[0001] This application claims priority to U.S. Provisional Patent Application No. 62/732,979, filed September 18, 2018, and is incorporated herein by reference in its entirety for all purposes.

Background 1. Technical field:
[0002] A tissue care device and method of using the same is disclosed. More specifically, expandable and/or contractible tissue care devices and methods of use thereof are disclosed.

2. Background technology:
[0003] There is a need for improved tissue care devices that promote healing, increase user comfort, reduce scarring, and provide reliable tissue traction.

Summary of the invention
[0004] The present disclosure generally relates to tissue care devices.

[0005] More specifically, tissue closure devices and methods of using the same are disclosed. The device may be expandable, collapsible, or both.

[0006] Tissue care devices (eg, wound care devices, pustule treatment devices) are disclosed. For example, tissue care devices have been disclosed that have device longitudinal axes. The device may have a tissue engager. The device may have a mount coupled to the tissue engager. The device may have a retractable band coupled to the mount.

[0007] Tissue care devices (eg, wound care devices, pustule treatment devices) are disclosed. For example, tissue care devices have been disclosed that have device longitudinal axes. The device may have a tissue engager. The device may have a retractable band coupled to the tissue engager.

[0008] A method for deploying a tissue care device (eg, wound care device, pustule treatment device) is disclosed. For example, a method for deploying a tissue care device having a longitudinal axis of the device is disclosed. The method may include expanding the equipment. The method may include attaching a device to the wound tissue. The method may include deflating the device to partially or fully close the wound.

Brief description of the drawing
[0009] The drawings shown and described are illustrative variations and are non-limiting. Like reference numbers indicate identical or functionally equivalent features throughout.

[0010] FIGS. 1A-1B illustrate changes in the state of a tissue care device and methods for expanding and deflating the device. [0011] FIG. 1A depicts a tissue care device in a device first configuration (eg, device retracted configuration). [0012] FIG. 1B depicts the tissue care device of FIG. 1A in a device second configuration (eg, device expansion configuration). [0013] FIGS. 2A-2B illustrate changes in the state of a tissue care device and methods for expanding and deflating the device. [0014] FIG. 2A depicts a tissue care device in a device first configuration (eg, device retracted configuration). [0015] FIG. 2B depicts the tissue care device of FIG. 2A in a device second configuration (eg, device expanded configuration). [0016] FIGS. 3A-3B illustrate changes in the state of a tissue care device and methods for expanding and deflating the device. [0017] FIG. 3A depicts a tissue care device in a device first configuration (eg, device retracted configuration). [0018] FIG. 3B depicts the tissue care device of FIG. 3A in a device second configuration (eg, device expanded configuration). [0019] FIGS. 4A-4B illustrate changes in the state of a tissue care device and methods for expanding and deflating the device. [0020] FIG. 4A depicts a tissue care device in a device first configuration (eg, device retracted configuration). [0021] FIG. 4B depicts the tissue care device of FIG. 4A in a device second configuration (eg, device expanded configuration). [0022] FIGS. 5A-5B illustrate changes in the state of a tissue care device and methods for expanding and deflating the device. [0023] FIG. 5A depicts a tissue care device in a device first configuration (eg, device retracted configuration). [0024] FIG. 5B depicts the tissue care device of FIG. 5A in a device second configuration (eg, device expanded configuration). [0025] FIGS. 6A-6B illustrate changes in the state of a tissue care device and methods for expanding and deflating the device. [0026] FIG. 6A depicts a tissue care device in a device first configuration (eg, device retracted configuration). [0027] FIG. 3B depicts the tissue care device of FIG. 6A in a device second configuration (eg, device expanded configuration). [0028] FIG. 7A shows the device of FIG. 1A taken along line 7A-7A with the device resting on a curved tissue surface. [0029] FIG. 7B shows the device of FIG. 1B taken along line 7B-7B with the device resting on a curved tissue surface. [0030] FIG. 7C shows the device of FIG. 1A taken along line 7A-7A with the device resting on a flat tissue surface. [0031] FIG. 7D shows the device of FIG. 1B taken along line 7B-7B with the device resting on a flat tissue surface. [0032] FIG. 8 illustrates changes in the state of a tissue care device and methods for expanding and deflating the device. [0033] FIGS. 9A-9E illustrate changes in the state of a tissue care device and a method for treating tissue. [0034] FIG. 9A depicts a tissue care device in a device first configuration (eg, device expansion configuration). [0035] FIG. 9B depicts the tissue care device of FIG. 9A in a device second configuration (eg, device retracted configuration). [0036] FIG. 9B-1 depicts the tissue care device of FIG. 9A in a device second configuration (eg, device retracted configuration). [0037] FIG. 9C shows the device of FIG. 9A taken along line 9C-9C with the device on a flat and/or curved surface. [0038] FIG. 9D shows the device of FIG. 9B taken along line 9D-9D with the device on a flat and/or curved surface. [0039] FIG. 9E shows the device of FIG. 9D with the solution applied to the surface of the tissue. [0040] FIGS. 10A-10E illustrate changes in the state of a tissue care device and a method for treating tissue. [0041] FIG. 10A depicts a tissue care device in a device first configuration (eg, device retracted configuration). [0042] FIG. 10B depicts the tissue care device of FIG. 10A in a device second configuration (eg, device expanded configuration). [0043] FIG. 10B-1 depicts the tissue care device of FIG. 10A in a device second configuration (eg, device expanded configuration). [0044] FIG. 10C shows the device of FIG. 10A taken along line 10C-10C with the device on a flat and/or curved surface. [0045] FIG. 10D shows the device of FIG. 10B taken along line 10D-10D with the device on a flat and/or curved surface. [0046] FIG. 10E shows the device of FIG. 10D with a solution applied to the surface of the tissue.

detailed description
[0047] A tissue care device is disclosed. The tissue care device may be and/or function as a wound closure device, a wound opener, a tissue closure device, a tissue opener, a tissue tensioner, a tissue constrictor, a tissue treatment device, or any combination thereof. For example, as a tissue treatment device, the device may be and/or function as a wound care device, pustule care device, lesion care device, or any combination thereof. The device may treat tissue. The tissue to be treated may include a wound, a pustule (eg, an acne), or both. For example, a tissue care device may close a wound, open a wound, or both. The wound may be an open wound, such as cuts, incisions, lacerations, abrasions, avulsions, puncture wounds, or any combination thereof. As another example, a tissue care device may stretch tissue, compress tissue, or both. As the device stretches or compresses the tissue, tension near the tissue of one or more pustules (eg, acne) may be relieved, eliminated, or both. Tissue care devices may be affixed directly or indirectly to tissue. The tissue care device partially or completely closes a lesion, pustule, wound, or any combination thereof. The tissue care device may partially or completely open a lesion, pustule, wound, or any combination thereof. The tissue care device may partially or completely relieve tissue pressure near one or more tissue pustules or lesions (eg, acne). The tissue care device may de-stretch or de-tension tissue on and/or near one or more tissue pustules or lesions (e.g., acne). .

[0048] Tissue care devices may be expandable, collapsible, or both. Tissue care equipment can be expanded. The tissue care device may be deflated. When expanded, the tissue care device can move the skin and underlying tissue. When deflated, the tissue care device can move the skin and underlying tissue. The tissue care device can move the skin and underlying tissue when expanded and deflated. For example, once the tissue care device is attached to tissue, the tissue care device may close the wound by contraction, open the wound by expansion, or both. As another example, when the tissue care device is attached to tissue, the tissue care device may move (e.g., push, pull) more tissue toward the pustule, causing the tissue care device to move (e.g., push, pull) more tissue toward the pustule. It can relieve pressure. When the device is deflated or expanded, the tissue care device may tension tissue, compress tissue, or both. A tissue care device may maintain a wound closed or open, for example, when the device is in a contracted or expanded configuration, respectively. The tissue care device may maintain tissue in the vicinity of the pustule in a less tense state so that the skin and tissue associated with and in the vicinity of the pustule are not stretched too much, thereby advantageously removing the pustule (e.g. acne ) may reduce scarring caused by Tissue care devices may maintain tissue in traction. Traction may include tension and/or compression of tissue, wounds, pustules, or any combination thereof. The tissue care device may retract tissue to close the wound. This allows the wound to heal. Maintaining the tissue in the desired healing position may advantageously reduce the time it takes to heal and reduce the amount of scar tissue that forms.

systems and equipment
[0049] FIGS. 1A and 1B illustrate changes in the state of a tissue care device 10 that can be removably attached to a substrate 8. Substrate 8 may be organic (eg, tissue), inorganic (eg, fabric), or both. For example, substrate 8 may be skin, a tissue dressing, or both. Tissue dressings can be wound dressings. A tissue dressing can have an absorbent portion, such as an absorbent layer. The tissue dressing may have a drug eluting portion, such as a drug eluting layer integrated with and/or separate from the absorbent layer. The tissue dressing may be a pustular dressing. Substrate 8 may have target tissue 6 . Target tissue 6 may be one or more wounds, lesions, pustules (eg acne), or any combination thereof. Instrument 10 may be positioned over the target tissue 6 . Device 10 may be positioned partially or completely around target tissue 6. Device 10 may extend partially or completely around target tissue 6.

[0050] Device 10 may have one or more engagers 12, one or more mounts 14, and one or more bands 16. Engagement element 12 may attach device 10 to substrate 8 . Mount 14 may couple band 16 to engager 12. Band 16 can be expanded. Band 16 is retractable. Band 16 can expand and contract. Device 10 may be expandable and retractable by band 16. For example, band 16 may be expanded and contracted to expand and contract device 10, respectively.

[0051] The engager 12 can secure the device 10 to the base material 8 with or without piercing the base material 8. Engagement element 12 may include one or more mechanical fasteners, chemical fasteners, or both. For example, the engager 12 may include an adhesive. Device 10 may be attached to substrate 8 by adhesive. Engagement element 12 may be an adhesive patch. Additionally or alternatively, the engager 12 may include one or more perforators (eg, staples), magnets, hooks, snaps, male connectors, female connectors, or any combination thereof. For example, the engager 12 can have a first fastener (e.g., adhesive) and a second fastener (e.g., adhesive, hook), where the first fastener attaches the engager 12 to tissue. The second fastener can attach the engager 12 to a tissue dressing (eg, a wound dressing). Engagement element 12 can be separate from the tissue dressing or can be attached to or integrated with the tissue dressing. Engagement element 12 may be flexible, rigid, or both. Engagement element 12 may be deformable.

[0052] The engager 12 may have a first engager portion and a second engager portion. The engager first portion may be removably attached to the substrate 8. Once attached to the substrate 8, the engager first portion may be in contact with the substrate 8 directly or indirectly, for example via adhesive or mechanical fasteners. The engager second portion may be attached to or integral with one or more of the mounts 14, such as by chemical or mechanical fasteners. The engager first and second portions of the engager may be flexible, rigid, or both. For example, the engager first portion may be flexible, allowing the device 10 to conform to the surface of the substrate 8, and the engager second portion may be rigid, allowing the band 16 to be removably attached to the mount 14. It can be installed.

[0053] The engager first portion and the second portion may be on opposite sides (eg, diametrically opposite each other). For example, the engager first portion may be on the engager first side (e.g., the engager bottom) and the engager second portion may be on the engager opposite the engager first side. It may be on the second side of the engager (e.g., on the top of the engager). The engager first portion can contact tissue and the engager second portion can have a mount 14.

[0054] The engager first portion and second portion may be adjacent to each other. For example, the engager first portion may be on the engager first side (e.g., the engager bottom) and the engager second portion may be on the engager next to the engager first side. It may be on the second side. The second side of the engager is the side of the engager that is between the top side and the bottom side of the engager, e.g., the side near the center of the device, the side sized away from the center of the device , or the sides extending between them.

[0055] Mount 14 may couple band 16 to engager 12, for example with or without one or more couplers 18. Coupler 18 may contact band 16 . For example, coupler 18 may wrap around a portion of band 16. Coupler 18 may be attached to or integrated with mount 14. The mounts and/or couplers 14, 18 may define one or more channels 20. Band 16 may be fixed within channel 20, movable within channel 20, or both. For example, the band 16 may become smaller as the device 10 becomes smaller (e.g., when the device 10 changes from the device expanded configuration to the device expanded configuration) or as the device 10 becomes larger (e.g., when the device 10 changes from the device expanded configuration to the device expanded configuration). ), or both. For example, band 16 may be translatable (eg, slidable) within channel 20, rotatable within channel 20, or both. Band 16 may be removably or non-removably attached to channel 20.

[0056] The mounts and/or couplers 14, 18 define one or more grooves into which the band 16 rests (e.g., the surface of the mount 14, the surface of the coupler 18, or both). The mounts and/or couplers 14, 18 define one or more grooves in which the band 16 moves (eg, the surface of the mount 14, the surface of the coupler 18, or both). For example, band 16 may be translatable (eg, slidable) within the groove, rotatable within the groove, or both. Coupler 18 may be a strap, hook, magnet, or any combination thereof. As another example, band 16 may be attached to or integrated with engager 12 without mount 14. Engagement element 12 may define a channel 20 and groove.

[0057] Mount 14 may enable, inhibit, or prevent movement of band 16 relative to mount 14. For example, band 16 may be attached to mount 14 by a loose fit, a restrictive fit, a friction fit, a snap fit, a magnetic fit, a glue fit, or any combination thereof. Band 16 is slidable within mount 14, for example within channel 20 or groove. Mount 14 may be flexible, rigid, or both. Mount 14 may be deformable. For example, engager 12 may be flexible and mount 14 may be rigid.

[0058] The engagers and mounts 12, 14 may be a modular assembly such that the engagers and mounts 12, 14 may be removably attached to each other. For example, the engager 12 may be removably attached to the mount 14, or vice versa. The engagers and mounts 12, 14 may be a modular assembly such that the engagers and mounts 12, 14 may be removably attached to the band 16. For example, the engager 12 may be removably attached to the band 16. As another example, mount 14 may be removably attached to band 16. As yet another example, the engagers and mounts 12, 14 may be removably attached to the band 16. This desirably allows for the use of different numbers of engagers and mounts 12, 14 with the same band 16, for example, to accommodate different shapes and sizes of target tissue 6. As another example, bands 16 having different sizes (eg, small, medium, large bands) may be used with device 10 to accommodate target tissues 6 of different shapes and sizes. This desirably allows the device 10 to be used with target tissues 6 of different sizes and shapes, and desirably allows the device 10 to treat the same target tissue 6 as the target tissue heals and becomes smaller. do. Band 16 may have different shapes to accommodate different wound shapes. The band shape may be shaped to follow the contours of the target tissue 6. The band shape may mirror the shape of the target tissue 6, e.g., a round band 16 for a round target tissue 6, a square band 16 for a square target tissue 6, an irregular shape for an irregularly shaped target tissue. band 16.

[0059] The band 16 may be attached to the engager and/or mount 12, 14 on the side opposite the substrate 8, for example, on the top surface of the engager and/or mount 12, 14. As another example, the band 16 may be attached to the engager and/or mount 12, 14 on one or more sides of the engager and/or mount 12, 14, where the sides are Or it may be between the top and bottom surfaces of the mounts 12,14. The engager and/or mount 12, 14 has an outer surface (e.g., the surface furthest from the center of the device), an inner surface (e.g., the surface closest to the center of the device), and an intermediate side extending therebetween. It is possible. Band 16 may be attached to or integrated with any of these surfaces.

[0060] Band 16 may be expandable, stretchable, contractible, compressible, collapsible, deployable, rotatable, translatable, telescopable, or any combination thereof. For example, the band 16 may be non-stretchable, but may be folded and unfolded, respectively, as the size of the band 16 (e.g., diameter across the device, maximum length, in any device configuration) increases or decreases. can. As another example, band 16 may be stretchable and may be folded and unfolded as band 16 increases or decreases in size, respectively. Band 16 may have a fixed length, variable length, or both. Band 16 may, for example, expand, elongate, contract, compress, fold, unfold, rotate, translate, fold, or the like in response to internal forces, external forces (e.g., forces applied to device 10), or both. Any combination of the following may be performed. The internal force may be an internal spring force of band 16. Internal forces may be internal to device 10 but external to band 16. For example, device 10 may include a spring that applies a force to band 16. The external force can be applied directly or indirectly by hand. External forces can be applied by instruments. The instrument may be removably engageable to device 10. The band 16 may be attached, for example, to the center of the device 10, to any one of the engagers 12 or mounts 14, to any group of engagers 12 or mounts 14, or to any combination thereof. For example, any portion of device 10 may be expanded, stretched, contracted, compressed, folded, unfolded, rotated, translated, folded, or any combination thereof.

[0061] Band 16 may be made of plastic, metal, composite material, or any combination thereof. For example, band 16 may be made of a shape memory alloy (eg, nitinol). As another example, band 16 may be made of a non-shape memory material (eg, a non-shape memory alloy). Band 16 may be elastic, inelastic, or both. Band 16 may be a spring. Band 16 may be made of one or more filaments. Filaments can be made from one or more materials. For band 16 with multiple filaments, band 16 may be braided or non-braided. Different filaments may be made of the same or different materials as another filament. For example, band 16 may have a first filament and a second filament. The first filament may be made of a first material, and the second filament may be made of a second material that is the same as or different from the first filament. When the first and second materials are different from each other, the first material may be elastic and the second material may be inelastic, the first material may be more elastic than the second material, the first material may be more elastic than the second material, the first material may be elastic and the second material may be inelastic. The material may be less elastic than the first material, or any combination thereof. The first and second filaments may be braided together. A single filament can have multiple longitudinal segments. The segments may be removably or permanently attached together. The different segments may be made of the same or different materials as the other filaments. For example, a band may have multiple first segments and multiple second segments. The first and second segments may alternate with each other such that a first segment (eg, each first segment) is between two second segments. The plurality of first segments may be made of a first material, and the plurality of second segments may be made of a second material that is the same as or different from the plurality of first segments. When the first and second materials are different from each other, the first material may be elastic and the second material may be inelastic, the first material may be more elastic than the second material, the first material may be more elastic than the second material, the first material may be elastic and the second material may be inelastic. The material may be less elastic than the first material, or any combination thereof. Band 16 may be an expandable column, for example made of struts and open cells. For example, the struts may define expandable and retractable toroids. The toroid may be closed (eg, forming a ring) or open (eg, forming an arc or polyline shape). As another example, band 16 may form a spiral. The spiral may form a closed or open toroid. Band 16 may be an expandable cage. As another example, band 16 may be made of multiple links. The links may be connected to each other by flexible or rigid joints. As another example, each link may be connected to one or more engagers 12 and/or one or more mounts 14, with or without being connected to another link. Links may have uniform size. There may be links of different sizes. Some or all of the links may be flexible. Some or all of the links may be rigid. Some links may be more flexible than others. For example, a first link may be more flexible than a second link. Some links may be more rigid than others. For example, the first link may be more rigid than the second link. The links may be connected together to form a band 16, for example a circular or polygonal band 16. The links may be straight, curved, bent, or any combination thereof. The links may be connected to form a polygonal band 16. The links may be connected to form an expandable cage. The links may be expandable cage struts.

[0062] Band 16 may be shape-locked in a closed configuration (also referred to as a collapsed configuration). Band 16 may be shape-locked in an open configuration (also referred to as an expanded configuration). The shape-fixed form of the band 16 may be the neutral form of the band 16. Bands 16 may be in a strained configuration when not in their neutral or fixed configuration. Bands 16 can be biased such that when expanded and/or contracted away from their neutral configuration, they automatically return to or toward their neutral configuration. For example, bands 16 may be expanded and/or contracted away from their neutral configurations, and then their neutral configurations may be expanded and/or contracted, respectively, when the expansion and/or contraction forces are released from device 10 (e.g., released from bands 16). or can be biased to automatically return to or in that direction. As another example, band 16 may be expanded and/or contracted away from the neutral configuration, and then the respective expansion and/or contraction forces are released from device 10 (e.g., released from band 16). They may automatically return to or revert to their neutral configuration.

[0063] All or a portion of band 16 may be shape-fixed. Band 16 does not need to be fixed in shape. All or a portion of band 16 may not be shape-fixed. One or more portions of band 16 may be shape-fixed. One or more portions of band 16 need not be fixed in shape. Band 16 may have one or more portions that are shape-fixed and one or more portions that are not shape-fixed. For example, a first portion of the band may be shape-fixed and a second portion of the band may not be shape-fixed.

[0064] Band 16 may be expanded and/or contracted with or without the use of instruments. Device 10 may be expanded and/or retracted with one hand, such as by band 16. Device 10 may be expanded and/or deflated with both hands. Device 10 may be expanded and/or retracted with one and/or two hands.

[0065] When band 16 is expanded or contracted, band 16 may change from a band first configuration to a band second configuration that is different from the band first configuration. The second configuration of the band may be more open than the first configuration of the band. The second configuration of the band may be more closed than the first configuration of the band. The band first configuration may be a fully collapsed configuration, a partially collapsed configuration, a partially expanded configuration, or a fully expanded configuration. The band second configuration may be a fully collapsed configuration, a partially collapsed configuration, a partially expanded configuration, or a fully expanded configuration. Band 16 may change form (eg, from a band first form to a band second form, or vice versa) by folding, unfolding, stretching, compressing, or any combination thereof. For example, band 16 may unfold and/or elongate as band 16 changes from a first configuration to a second configuration that is more open than the first configuration. As another example, band 16 may be folded and/or compressed as band 16 changes from a first configuration to a second configuration that is less open than the first configuration. For example, FIGS. 1A and 1B show that band 16 can have a band first configuration (FIG. 1A) and a band second configuration (FIG. 1B), where the band second configuration is different from the band first configuration. This shows that the difference is larger than the shape.

[0066] The device 10 may be in the device first configuration, for example, when the band 16 is in the band first configuration (eg, FIG. 1A) and when the band 16 is in the band second configuration (eg, FIG. 1B), respectively. (eg, FIG. 1A) and a device second configuration (eg, FIG. 1B). Band 16 may control the size of device 10. Band 16 may change the size of device 10. Band 16 may be manipulated to control the size of device 10. Band 16 may be manipulated to increase the size of the device, decrease the size of the device, or both. As another example, one or more of the engagers 12 and/or mounts 14 may be manipulated to increase or decrease the size of the device, and when the one or more engagers 12 and/or mounts 14 are manipulated, , allowing the band 16 to expand and/or contract.

[0067] The device first configuration may be a device neutral configuration, an open device configuration, an expanded device configuration, a closed device configuration, a collapsed device configuration, or any combination thereof. The device-neutral configuration may be a device-unexpanded configuration, a device-expanded configuration, a device-unretracted configuration, a device-retracted configuration, or any combination thereof. The device second configuration may be a device neutral configuration, a device expanded configuration, a device retracted configuration, or any combination thereof. The device 10 may change from a first device configuration to a second device configuration. When device 10 changes from a first device configuration to a second device configuration, device 10 may increase in size or decrease in size. The device 10 may change from a second device configuration to a first device configuration. As the device 10 changes from the device second configuration to the device first configuration, the device 10 may increase in size or decrease in size. For example, the size of device 10 can be increased from a device neutral configuration, a device expanded configuration, a device collapsed configuration, or any combination thereof (eg, device 10 can be expanded). As another example, the size of device 10 may be reduced from a device neutral configuration, device expanded configuration, device collapsed configuration, or any combination thereof (eg, device 10 can be collapsed).

[0068] A device may have one or more neutral forms. For example, an equipment neutral configuration may correspond when bands 16 are in their shape-fixed configuration. As another example, a device neutral configuration may correspond when band 16 is in a relaxed state or in a relaxed state to the maximum extent allowed by device 10. A relaxed state may correspond to an unextended state, or a partially unrelaxed state (eg, a partially extended state). The device 10 may be variable from a first device configuration to a second device configuration, from a second device configuration to a first device configuration, or both. For example, FIG. 1A shows device 10 in a device-neutral configuration, and FIG. 1B shows device 10 in a device-non-neutral configuration. As another example, FIG. 1A shows device 10 in a device-non-neutral configuration, and FIG. 1B shows device 10 in a device-neutral configuration. As yet another example, FIG. 1A shows device 10 in a device non-neutral configuration, and FIG. 1B shows device 10 in a device non-neutral configuration.

[0069] The device may have a central device axis A ₁ . The device 10 may extend symmetrically or asymmetrically away from the central device axis _A1 . For example, FIGS. 1A and 1B show that the device 10 can be expanded symmetrically away from the central device axis A ₁ . When the device 10 is in a first device configuration (eg, FIG. 1A), the engager 12, mount 14, and/or band 16 may be a first distance apart from the device central axis _A1 . When the device 10 is in the device second configuration (e.g., FIG. 1B), the engager 12, mount 14, and/or band 16 may be at a second distance from the device central axis _A1 , where: The second distance may be longer than the first distance. The target tissue 6 may be centered or offset relative to the device central axis A ₁ when the device is in the device first configuration. The target tissue 6 may be centered or offset with respect to the instrument central axis A ₁ when the instrument is in the instrument second configuration. For example, FIGS. 1A and 1B show that the device central axis A ₁ may coincide with the central region of the target tissue 6 (eg, the central axis of the target tissue 6).

[0070] The device 10 may have a device first maximum dimension L ₁ when the device 10 is in the device first configuration (eg, FIG. 1A). Dimension _L1 may be, for example, as measured between two points on the outer circumference of the device 10, as measured between two points on the inner circumference of the device 10, or on opposite sides of the device 10. Between any two points (e.g., a point on the first engager 12, the first mount 14, or a point on the first portion of the band 16 and a point on the second engager 12, the second mount 14) or points on the second portion of the band 16, where the points are on opposite sides of the device 10). Dimension L ₁ may be the maximum length across the device 10 when it is in the device first configuration. Dimension L ₁ may be, for example, from about 1 cm to about 50 cm, including all 1 cm increments within this range (eg, 2 cm, 4 cm). Dimension L ₁ may be the diameter of device 10 . Dimension L ₁ may be, for example, from about 1 cm to about 50 cm, including all 1 cm increments within this range (eg, 1 cm, 2 cm, 10 cm). FIG. 1A shows, for example, that the device 10 may have a dimension L ₁ along the device first transverse axis A ₂ and the device second transverse axis A ₃ .

[0071] The device 10 may have a device second maximum dimension L ₂ when the device 10 is in the device second configuration (eg, FIG. 1B). Dimension _L2 may be, for example, as measured between two points on the outer circumference of the device 10, as measured between two points on the inner circumference of the device 10, or on opposite sides of the device 10. Between any two points (e.g., a point on the first engager 12, the first mount 14, or a point on the first portion of the band 16 and a point on the second engager 12, the second mount 14) or points on the second portion of the band 16, where the points are on opposite sides of the device 10). Dimension _L2 may be the maximum length across the device 10 when it is in the second device configuration. Dimension L ₂ may be, for example, from about 1 cm to about 50 cm, including all 1 cm increments within this range (eg, 5 cm, 10 cm, 15 cm). Dimension L ₂ may be the diameter of device 10 . Dimension L ₂ may be, for example, from about 1 cm to about 50 cm, including all 1 cm increments within this range (eg, 1 cm, 2 cm, 10 cm). FIG. 1B shows, for example, that the device 10 may have a dimension L ₂ along the device first transverse axis A ₂ and the device second transverse axis A ₃ .

[0072] The length of band 16 may be the same or different in the contracted and expanded configurations. For example, band 16 may have the same length in the expanded configuration as in the contracted configuration (eg, if band 16 is collapsible and expandable). As another example, band 16 may be longer in length in the expanded configuration than in the contracted configuration (eg, where band 16 is capable of stretching and de-stretching).

[0073] The diameter of band 16 may be the same or different in the contracted and expanded configurations. For example, band 16 may have the same diameter in the expanded configuration as in the contracted configuration (eg, when band 16 is folded and unfolded). As another example, band 16 may have a longer diameter in the expanded configuration than in the contracted configuration (eg, where band 16 is capable of stretching and de-stretching).

[0074] Band 16 may have a band longitudinal axis that follows the shape of band 16. The band longitudinal axis may be the central longitudinal axis of band 16. Band 16 may be straight and/or curved. Band 16 may have a zigzag pattern (also referred to as a waveform). The corners of the zigzag pattern may be sharp (eg, pointed) or rounded. A zigzag pattern can have a sinusoidal shape (eg, curved, square) with branches and corners. The branches may be rigid and the corners may be flexible. As another example, corners may be more flexible than branches. Band 16 may be undulating in one or more planes. 1A and 1B show that band 16 can have a wavy shape (e.g., a sinusoidal shape) with branches and corners, where each branch between adjacent corners of band 16 is , indicating that it can be attached to mount 14.

[0075] FIG. 1A further shows that when the device 10 is in the closed state (also referred to as the retracted configuration), the band longitudinal axis along the branch is about the same as the longitudinal axis of the engager 12, the mount 14, or both. The alignment angle may be from 0 degrees to about 45 degrees, inclusive of all 1 degree increments within this range (eg, 5 degrees, 10 degrees, 15 degrees, 20 degrees). Such an alignment angle may desirably improve force transmission between the device 10 and the substrate 8. FIG. 1B further shows that when the device 10 is in the open state (also referred to as the expanded configuration), the band longitudinal axis along the branch is between about 0 degrees and the longitudinal axis of the engager 12, the mount 14, or both. It may be at an alignment angle of approximately 45 degrees, indicating that it includes all 1 degree increments within this range (eg, 5 degrees, 10 degrees, 15 degrees, 20 degrees). Such an alignment angle may desirably improve force transmission between the device 10 and the substrate 8. The alignment angle may be the same or different when device 10 is in the retracted and expanded configurations. For example, the band longitudinal axis may be greater when the device 10 is in the retracted configuration (e.g., fully retracted configuration) than when the device 10 is in the expanded configuration (e.g., fully expanded configuration). It may be closely aligned with both longitudinal axes (eg, by about 5 degrees, 10 degrees, 15 degrees).

[0076] Band 16 may have a bulge 22 configured to engage engager 12, mount 14, or both. The bulge 22 may be attached to or integrated with the band 16. The bulge 22 may extend away from the band longitudinal axis. The bulges 22 may have a spherical shape, a pearl shape, a bead shape, or any combination thereof. The bulge 22 may be a ramp. The bulge 22 may be a hook. Bulges 22 may be one or more extensions away from band 16. The bulge 22 may cause the device 10 to change, e.g., by inhibiting or preventing the band 16 from slipping off the engager and/or mounts 12, 14 when the device 10 changes from an expanded configuration to a contracted configuration, or vice versa. may allow for controllable opening and/or closing of. For example, bulge 22 is sized so that it does not pass through channel 20, allowing bulge 22 to push against mount 14 when device 10 closes or opens. When bulge 22 is pressed against mount 14, bulge 22 may become attached to mount 14 (e.g., within channel 20) by a friction fit, a snap fit, a magnetic fit, or any combination thereof. .

[0077] The bulges 22 may be uniformly disposed on the band 16 around the device 10, for example, in a uniformly shaped target tissue 6 (eg, a target tissue having symmetry about two vertical axes). The bulges 22 may be disposed non-uniformly on the band 16 around the device 10, for example, in irregularly shaped target tissues 6 (e.g., target tissues that are asymmetrical or symmetrical about one axis). for example, in a pattern or irregularly).

[0078] Band 16 may be closed (eg, forming a loop) or open (eg, forming an arc or polyline shape). For example, band 16 may be a ring (eg, a Nitinol ring). In a closed device 10 where the bands 16 form a loop, one or more of the bands 16 forming the loop may define an opening 24 in the device 10. Opening 24 may be the central opening of device 10. Opening 24 may have a circular, oval, polygonal (eg, diamond), and/or irregular shape. In open devices 10 where one or more bands 16 do not form a loop, opening 24 may be hollow. The cavity may have a shape that is partially circular, oval, polygonal (eg, diamond), irregularly shaped, or any combination thereof. Openings 24 may desirably allow target tissue 6 to breathe during the healing process. Band 16 may have a regular or irregular cross-sectional shape, such as circular, oval, stadium, polygonal (eg, diamond-shaped, star-shaped), or any combination thereof.

[0079] Device 10 may have an opening 26. Aperture 26 may be the same as or different from aperture 24. Opening 26 may be the central opening of device 10. Openings 26 may expose target tissue 6 when band 16 is in the expanded and/or contracted configuration. Opening 26 may desirably allow target tissue 6 to breathe during the healing process.

[0080] When device 10 is expanded and deflated, the sizes of openings 24 and 26 may increase and decrease, respectively. Openings 24 and/or 26 may desirably allow access to target tissue 6 when device 10 is attached to substrate 8. Openings 24 and 26 are also referred to as tissue access ports. The tissue access ports (eg, opening 24, opening 26) can have a port area from about 1 cm ² to about 1000 cm ² or more, including all 1 cm ² increments within this range. For example, the tissue access port may have a port area of approximately 30 cm ² when device 10 is in the expanded configuration and may have a port area of approximately 10 cm ² when device 10 is in the collapsed configuration.

[0081] Band 16 may be deformable, for example elastically deformable. Band 16 may be modified into one or more configurations. Band 16 may be deformed to close target tissue 6, open target tissue 6, or both. For example, band 16 may expand and contract when device 10 is attached to substrate 8.

[0082] FIGS. 1A and 1B further illustrate that there may be gaps 29 or channels 29 between adjacent engagers and/or mounts 12, 14. These advantageously allow the target tissue 6 or wound dressing to breathe more. This may be particularly beneficial if a cover is placed over the top of the target tissue access ports 24,26. FIG. 1A shows that some of the gaps 29 may be closed when the device 10 is in the closed configuration. As another example, all of the gaps 29 may be open when the device 10 is in the closed configuration. FIG. 1B shows that all of the gaps 29 can be opened when the device is in the open configuration.

[0083] FIGS. 1A and 1B further illustrate that the gaps or channels between adjacent engagers and/or mounts 12, 14 are more expanded in the device first configuration (e.g., FIG. 1B) than in the device first configuration. The second form of the device (eg, FIG. 1A) is shown to be wider than the second form (eg, FIG. 1A), which is less or more contracted. For example, the dimensions (e.g., lengths) between adjacent engagers and/or mounts 12, 15 range from about 2 mm to about 20 mm for a first configuration of the device, and from about 0 mm to about 18 mm for a second configuration of the device. It can reach up to

[0084] Figures 2A and 2B show that device 10 may have a cover 30 (also referred to as a tissue cover). Cover 30 may be removably attached to the engager, mount and/or band 12, 14, 16. For example, FIGS. 2A and 2B show that cover 30 can be removably attached to mount 14. Cover 30 may partially or completely cover openings 24 and/or 26. Cover 30 may advantageously protect target tissue 6 from contamination. Cover 30 may have a flap 32 that allows access to target tissue 6. As another example, the edges of cover 30 may be removably attachable to allow access to target tissue 6. Cover 30 may be a filter. For example, cover 30 may be an air filter, a wound exudate filter, or both. The side of the cover 30 (eg, the side configured to face the tissue) may be and/or have a wound dressing for the target tissue 6. The wound dressing may be configured to contact the target tissue 6. When the device is in the device first configuration (eg, FIG. 2A), the cover 30 and/or the wound dressing may contact the target tissue 6. When the device is in the device second configuration (eg, FIG. 2B), the cover 30 and/or the wound dressing may contact the wound. The cover 30 and/or wound dressing may be removed, for example, after a predetermined treatment period, after the cover and/or wound dressing has become saturated with wound exudate, or after the cover and/or wound dressing has become unhygienic. It may be replaced or replaced with a second covering and/or wound dressing. Cover 30 may be translucent. Cover 30 may be transparent. Cover 30 may be opaque.

[0085] FIGS. 3A and 3B show that cover 30 may have flaps 32. FIG. The side of the cover 30 (eg, the side configured to face the tissue) may be and/or have a wound dressing for the target tissue 6. The side of the flap 32 (eg, the side configured to face the tissue) may be and/or have a wound dressing for the target tissue 6. The wound dressing may be configured to contact the target tissue 6. When the device is in the device first configuration (eg, FIG. 3A), the cover 30, flap 32, and/or wound dressing may contact the target tissue 6. When the device is in the device second configuration (eg, FIG. 3B), the cover 30, flap 32, and/or wound dressing may contact the wound. The cover 30, flap 32, and/or wound dressing may be removed, for example, after a predetermined treatment period, after the cover, flap, and/or wound dressing is saturated with wound exudate, or after the cover, flap, and/or wound dressing is removed. After becoming unhygienic, it may be replaced or replaced with a second cover, a second flap, and/or a second wound dressing. Flap 32 may be translucent. Flap 32 may be transparent. Flap 32 may be opaque.

[0086] Cover 30 may be expandable, non-expandable, or both. Flap 32 may be expandable, non-expandable, or both. Cover 30 and/or flap 32 may be made of elastic material and may be adapted to the size of device 10 when device 10 is in the device first configuration and when device 10 is in the device second configuration.

[0087] FIGS. 4A and 4B show that device 10 may have a negative pressure wound therapy system 33. Negative pressure wound therapy system 33 may include a pump 34 and a wound exudate reservoir 36. Pump 34 may be battery powered. One or more tubes 38 may connect the target tissue 6 to the pump and canisters 34, 36. When negative pressure is applied to the target tissue 6 by the pump 34, wound exudate can be drawn up from the target tissue 6 into the reservoir 36. Reservoir 36 may be removably attached to device 10, for example by tube 38. Reservoir 36 may be removably attached to device 10, such as one or more of engagers 12, one or more of mounts 14, band 16, or any combination thereof. Tube 38 may have a one-way flow valve 39 that allows flow out of the wound, but not flow into the wound. As another example, tube 38 does not have a one-way flow valve 39. As yet another example, device 10 does not have a one-way flow valve 39.

[0088] FIGS. 4A and 4B further illustrate that the device 10 may have one or more skirts 40 configured in conjunction with the cover 30 to close the wound from the external environment. The device 10 may have a skirt 40 between every two adjacent engagers and mounts 12,14. As another example, as shown in FIGS. 4A and 4B, for example, the device 10 may have a single skirt 40 extending along the inner circumference of the device 10. Skirt 40 may have a port 41 for tube 38. The device 10 may have one or more skirts 40 with or without a negative pressure wound therapy system 33. Skirt 40 may be translucent. Skirt 40 may be transparent. Skirt 40 may be opaque. Skirt 40 may be expandable, non-expandable, or both. Skirt 40 may be made of an elastic material so that it may conform to the size of device 10 when device 10 is in the device first configuration and when device 10 is in the device second configuration.

[0091] FIGS. 5A and 5B show that the band 16 can have a wavy shape (e.g., a sinusoidal shape), where some of the branches between adjacent corners of the band 16 are attached to the mount 14. and that some of the branches between adjacent corners of band 16 do not need to be attached to mount 14. 5A and 5B further show that the device 10 may have a non-circular shape, for example an oblong shape or a stadium shape. This may be beneficial, for example, if the length of the target tissue 6 is greater than the width, or vice versa. Length or width may be the longer dimension. For example, FIGS. 5A and 5B show that the length can be greater than the width. The length of target tissue 6 can be from about 1 cm to about 25 cm or more, including all 1 cm increments within this range (eg, 4 cm). 5A and 5B further illustrate that the longitudinal axes of the band branches are aligned with the longitudinal axes of the engagers and/or mounts 12, 14 when the device is in the retracted configuration, the expanded configuration, and in between. Indicates that it can be left as is.

[0092] FIG. 6A shows that the engager 12 may have an annular shape. Engagement element 12 may be the rim of a tissue dressing (eg, a wound dressing).

[0093] Figure 6A further shows that mount 14 may have an annular shape. For example, mount 14 may be a wire loop.

[0094] FIG. 6A further shows that the device 10 may have a tensioner 28 across the device 10. Tensioner 28 may be a self-ratcheting cable. Tensioner 28 may maintain device 10 in an open or closed condition. Tensioner 28 may be attached to or integrated with the engager and/or mounts 12, 14. Tensioner 28 may be removed from device 10 after device 10 has been deflated the desired amount. Tensioner 28 may be removed, for example, after device 10 is locked in the retracted configuration using one or more locking mechanisms. Device 10 may remain in the retracted state after tensioner 28 is removed. After tensioner 28 is removed, it may be reattached to device 10 to further deflate or re-expand device 10, and then tensioner 28 may be removed again. Tensioner 28 may be integrated with or attached to cover 30, flap 32, wound dressing, or any combination thereof.

[0095] FIG. 6B shows that the band 16 may have less corrugation in the expanded configuration than in the contracted configuration, or vice versa.

[0096] Device 10 may have a ratchet component to maintain device 10 in an expanded or contracted state.

[0097] Device 10 may have one or more stops configured to inhibit or prevent device 10 from over-deflating or over-expanding. Stops are also referred to as contraction limits and expansion limits. For example, the engagers and/or mounts 12, 14 may be configured to contact each other when the device 10 is in a fully retracted state to prevent over-deflation of the device 10. When the device 10 reaches its maximum retracted state, the first engager and/or mount 12, 14 may contact the second and/or third engager and/or mount 12, 14, for example. In this manner, the engagers and/or mounts 12, 14 may resist over-deflation of the device 10. As another example, when the device 10 is in its fully retracted state, the engager and/or mount 12, 14 may have an extension configured to contact another extension, engager, or mount. may have. When in contact, the extension may resist further contraction of the device 10. The extensions may be, for example, flanges or legs of the engager and/or mounts 12,14. A linkage may be placed between two or more of the engagers and/or mounts 12, 14 and coupled to one or both of them to prevent over-expansion. As another example, the linkage may be disposed along and attached to band 16. The linkage may be flexible or rigid. For example, the linkage may be a flexible cable, line, or thread. The linkage may be slack when the device is not fully retracted, and may be taut when the device 10 is fully retracted. The linkage may thereby resist over-expansion. As a further example, band 16 may serve as a stop. For example, band 16 may be shape-fixed to have maximum expanded and contracted configurations. In this manner, band 16 may be taut to prevent over-contraction and over-expansion, for example, by being taut after unfolding, folding, stretching, compression, or any combination thereof. Bands 16 can thereby define their own range of expansion and contraction. Device 10 can be further deflated without one or more stops. Device 10 can be further deflated without one or more stops.

[0098] The state of maximum contraction may be quantified as a maximum contraction threshold. The maximum expansion state may be quantified as a maximum expansion threshold. These thresholds may be determined by comparing the parameters of the device 10 in two of the following configurations: a maximally contracted configuration, a neutral configuration, and a maximally expanded configuration. The parameters may include the size of the bands 16 (e.g., their circumference), the length, width, or height of the device 10, the area of the openings 24 or 26, the spacing between adjacent engagers and mounts 12, 14, or Any combination thereof may be used. The contraction and expansion thresholds may be a ratio of any of these values. For example, the parameters of the device 10 in the maximally deflated state may be about 5% to about 500% less than the parameters of the device 10 in the neutral or maximally expanded state, in 10% increments within this range. (eg, 25%, 50%, 75%, or 100%). As another example, the parameters of the device 10 in the maximally expanded state may be about 5% to about 500% greater than the parameters of the device 10 in the neutral or maximally contracted state, in 10% increments within this range. (eg, 25%, 50%, 75%, or 100%).

[0099] The device 10 may have 2 to 20 or more engagers 12, including all increments of one engager within this range. The device 10 may have from two to twenty or more mounts 14, including all one-mount increments within this range. The number of engagers 12 may be the same as or different from the number of mounts 14. Instrument 10 may have from one to ten or more bands 16, including all one-band increments within this range.

[0100] Device 10 may have a height. The height may be measured along an axis perpendicular to the surface of the substrate 8. The height can be, for example, from about 2 mm to about 15 mm, including all 1 mm increments within this range (eg, 2 mm, 4 mm, 6 mm, 10 mm). At such heights, the device 10 may have a low profile so that it may be worn under clothing, for example. The low profile of the device 10 may limit the interference that the device 10 may cause to the user's movements while wearing the device 10.

[0101] Device 10 may include a tissue dressing (eg, a wound dressing). As another example, device 10 may be attached to or integrated with a wound dressing.

[0102] Device 10 may include a negative pressure wound therapy device. As another example, device 10 may be attached to or integrated with a negative pressure wound therapy device. Device 10 and/or the negative pressure wound therapy device may have a pump that may be connected to a source of negative pressure and/or may generate negative pressure.

[0103] Device 10 may have electronics such as one or more sensors, a processor, a power source, and a transceiver. For example, device 10 may have a temperature sensor that may monitor the temperature of target tissue 6. Device 10 may have chemical sensors that may recognize one or more fluid components that may be monitored within the wound exudate flowing from target tissue 6. The sensor may include one or more engagers 12, one or more mounts 14, one or more bands 16, a cover 30, a flap 32, a skirt 40, a wound dressing, a negative pressure wound therapy system 33, or any combination thereof. may be attached to or integrated therewith.

[0104] The device 10 may have a wound exudate reservoir that may collect wound exudate as it flows from the target tissue 6.

[0105] The device 10 may contain natural and/or synthetic tissue treatment agents, drugs (e.g., anti-inflammatory drugs, local anesthetics), antibiotics, nutrients, creams, lotions, moisturizers, or any combination thereof. , may have one or more solutions. For example, the covering and/or tissue dressing may have any combination of solutions for application directly to the body, for indirect application to the body, or both. As another example, device 10 may have one or more solution reservoirs, where each reservoir may have any combination of one or more solutions. The device 10 may spray the solution onto the tissue, apply the solution directly to the tissue by means of a tissue cover (also referred to throughout as a wound cover), or any combination thereof. The solution may be, for example, a liquid or a gel. Device 10 may apply one or more solutions to the skin.

[0106] The solution may be released into the tissue, onto the tissue (eg, topical application), or both. For example, the solution may be released into and/or onto the target tissue 6. The solution may be released from the device 10 all at once or in sustained release over, for example, 1 to 8 hours, 1 to 24 hours, 1 to 7 days. Device 10 may release solution at a constant or variable rate over a predetermined period of time. Device 10 may release the solution independent of tissue conditions, eg, independent of target tissue conditions, independent of tissue conditions surrounding the target tissue, or independent of both. As another example, the device 10 may release the solution depending on the tissue conditions, e.g., depending on the target tissue conditions, depending on the tissue conditions surrounding the target tissue 6, or both. obtain. For example, the device 10 may be affected by a change in temperature conditions near the device 10, including, for example, temperature conditions, chemical conditions, wound exudate flow conditions, target tissue wetness or dryness conditions, user pain conditions, or any combination thereof. One or more solutions may be released based on one or more conditions. Device 10 determines or senses these conditions using, for example, one or more sensors (e.g., using a temperature sensor, a chemical sensor, a humidity sensor, a flow sensor, or any combination thereof). It is possible. The temperature condition may be tissue temperature, environmental temperature, or both. For example, the temperature condition may be the temperature of the target tissue, of the tissue surrounding the target tissue, of the air temperature outside the device 10, of the air within the device 10 (e.g., if there is a wound cover), or any combination thereof. obtain. The chemical conditions can be, for example, the chemical composition of tissue exudate (eg, wound exudate). For a user's pain condition, device 10 may have or be associated with a controller (e.g., wired or wirelessly) in which the user inputs the user's pain level, e.g., on a scale of 1 to 10. where 1 is the lowest pain level and 10 is the highest pain level, the solution can be released from the device 10 based on input from the user. For example, the device 10 may release more solution at higher pain levels than at lower pain levels, or vice versa.

[0107] Device 10 may have one or more patches configured to deliver one or more solutions onto tissue, into tissue, or both. For example, device 10 may include one or more medicated patches. Device 10 may have one or more iontophoresis patches and/or one or more electroporation patches to help drive the drug into tissue. The patch may be removably attachable to device 10. The patch may be disposable and may be replaced or changed with or without the device 10 attached to the user's body. The patch can be separated from the tissue dressing. The patch may be a tissue dressing. The patch may be integrated with or attached to a tissue dressing.

[0108] Device 10 may be a single-use device or a multiple-use device. Device 10 may be disposable. Instrument 10 may be sterilizable.

[0109] A user may wear device 10 while awake, while sleeping, or both.

[0110] Device 10 may include a suture threader or may be a sutureless device.

[0111] Instrument 10 may include a tissue cutter.

[0112] Device 10 may function as a tissue spreader, tissue obturator, tissue mover, or any combination thereof. Device 10 may function as a wound opener, wound closure, tissue mover, or any combination thereof. Instrument 10 may open a wound, close a wound, move tissue, or any combination thereof. Device 10 may be a tissue mover. Device 10 may be a solution application tool, where device 10 may apply a solution to target tissue. Device 10 may be a target tissue protector, where device 10 may be a physical barrier to protect target tissue 6.

[0113] FIGS. 7A-7D show that device 10 can conform to the shape of tissue 8. FIG. For example, the device 10 may conform to the shape of a body surface, such as a limb, a torso (e.g., back, abdomen, chest), a neck, a head (e.g., forehead, cheeks), or any combination thereof. . The device 10 can fit on a flat surface. The device 10 may be positionable on a plane. The device 10 can conform to curved surfaces. Device 10 may be positionable on a curved surface. Instrument 10 may bend along any axis away from a flat planar surface, for example. The device 10 may be flat, convex, concave, or conformable to any combination thereof. The device-neutral configuration may be a flat configuration, a curved configuration, or both. The device 10 may be designed for flat surfaces. Instrument 10 may be designed for curved surfaces. An instrument 10 designed for a flat surface may be positionable on a flat surface, a curved surface, or both. An instrument 10 designed for a flat surface may be adapted to a flat surface or any curved surface (eg, convex and/or concave). Instrument 10 designed for curved surfaces may be positionable on flat surfaces, curved surfaces, or both. An instrument 10 designed for curved surfaces may be adapted to flat surfaces or surfaces with any curvature (eg, convex and/or concave). When device 10 is positioned over tissue 8, band 16 may or may not be able to contact tissue 8.

[0114] FIGS. 7A and 7B illustrate that device 10 can be attached to a non-planar surface of tissue.

[0115] Figures 7C and 7C show that device 10 can be attached to a flat tissue surface.

[0116] FIG. 8 shows that the device 10 may have one or more tabs 42. Tab 42 may be a pull tab. Tab 42 may be an attachment device. The device 10 may have, for example, 1 to 10 or more tabs 42, and all increments of 1 tab within this range (eg, 2 tabs, 4 tabs, 10 tabs) include. Device 10 may have the same number of tabs as engagers 12. The device 10 may have one tab 42 per 2 to 10 engagers 12, in increments of 1 tab within this range (e.g., 1 tab 42 per 2 engagers 12, one tab 12 per three engagers 12, one tab 12 per four engagers 12), or any combination thereof. Tab 44 may cover the adhesive on engagement element 12. For example, once removed (e.g., pulled) from the engager, the adhesive may be exposed, as indicated by removal (e.g., pull) arrow 44. Once the adhesive is exposed, device 10 may be removably attached to tissue 8 by engager 12. Tab 42 may be paper, plastic, or composite material. For example, tab 42 may be a cardboard pull tab. Tabs 42 may be removed together or in any order, where device 10 has multiple tabs 42 (eg, device 10 of FIG. 8). Device 10 may be fully or at least partially expanded or retracted from removal of tab 42 from device 10 (e.g., if arrow 44 is directed in the opposite direction from that shown in FIG. 8). . As another example, tab 42 may be removed from device 10 independent of expansion or contraction of device 10, with or without instruments, and/or with or without the use of one or both hands. It can be done.

[0117] The first configuration of the device may be an expanded configuration of the device, eg, a partially expanded configuration or a fully expanded configuration. The device first configuration may be a device retracted configuration, such as a partially expanded configuration or a fully collapsed configuration. The device first form may be a device neutral form. The equipment-neutral configuration may be an equipment expansion configuration, such as a partial equipment expansion configuration or a maximum equipment expansion configuration. The device neutral configuration may be a device retracted configuration, such as a partially device retracted configuration or a fully device retracted configuration.

[0118] The second configuration of the device may be an expanded configuration of the device, such as a partially expanded configuration or a fully expanded configuration. The device second configuration may be a device retracted configuration, such as a partially expanded configuration or a fully collapsed configuration. The device second form may be a device neutral form. The equipment-neutral configuration may be an equipment expansion configuration, such as a partial equipment expansion configuration or a maximum equipment expansion configuration. The device neutral configuration may be a device retracted configuration, such as a partially device retracted configuration or a fully device retracted configuration. The device retracted configuration may be a closed configuration. The equipment extension configuration may be an open configuration. The first form of equipment may have a smaller aperture than the second form of equipment, or vice versa. The device retracted configuration may have a smaller opening than the device expanded configuration, such that the tissue access port has a smaller area in the device retracted configuration than in the device expanded configuration.

[0119] When the device 10 changes from the device first configuration to the device second configuration, the length of the device may increase from dimension L ₁ to dimension L ₂ . When the device changes from a first device configuration to a second device configuration, the length of the device may decrease from dimension L ₁ to dimension L ₂ .

[0120] When the device 10 changes from the device second configuration to the device first configuration, the length of the device may increase from dimension L ₁ to dimension L ₂ . When the device changes from the device second configuration to the device first configuration, the length of the device may decrease from dimension L ₁ to dimension L ₂ .

how to use
[0121] Device 10 may be expanded and/or deflated with or without instruments. The instrument may include an elongated shaft. The instrument shaft may have a length that exceeds the width of the instrument 10.

[0122] Device 10 may be attached to substrate 8 with or without instruments. The instrument may include an elongated shaft. The instrument shaft may have a length that exceeds the width of the instrument 10. The device may be a tab 42.

[0123] The instruments that may expand and/or deflate the device 10 may be the same or different than the instruments that may attach the device 10 to the substrate 8. For example, the device may be a constrictor, dilator, applicator, or any combination thereof. The instrument may be removably attached to device 10. For example, instruments may be removably attached to one or more engagers, mounts and/or bands 12, 14, 16 of device 10. Additionally or alternatively, device 10 may have an instrument connector to which instruments may be attached.

[0124] Device 10 may have the same or different shapes in the collapsed and expanded configurations. Device 10 may have an increasing size, a decreasing size, or both. For example, device 10 may have an increasing circumference, a decreasing circumference, or both. Device 10 may have a maximum size and a minimum size. For example, the device may have a larger size when the device is in the device second configuration (eg, FIG. 1B) than when the device is in the device first configuration (eg, FIG. 1A).

[0125] FIG. 1A shows that the device 10 may be in a partially or fully collapsed configuration before it is expanded and then placed on the substrate 8. FIG. 1A further shows that after the device 10 is attached to the substrate 8, the device 10 can return or be returned to a partially or fully contracted configuration.

[0126] FIG. 1B shows that the device 10 may be partially or fully expanded and then placed on the substrate 8.

[0127] FIGS. 1A and 1B show that before the device 10 is placed on the substrate 8, the device 10 changes from the device first form (for example, FIG. 1A) having the device first size to the device first size. Figure 1B shows that the device can be expanded to a device second form (eg, FIG. 1B) having a device second size larger than the device size. Once the device 10 is in the device second configuration (eg, FIG. 1B), the device 10 may be collapsed to a size smaller than the device second size. For example, the device 10 may be deflated to a size smaller than the second size, returned to the device first configuration having the first size (e.g., FIG. 1A), or the first size and the second size. can be shrunk to a size between . As another example, FIGS. 1A and 1B show that before the device 10 is placed on the substrate 8, the device 10 is transferred from a device second configuration (e.g., FIG. 1B) having a device second size to a device first configuration (e.g., FIG. 1B). Figure 1A shows that the device can be collapsed into a first configuration (eg, Figure 1A) having a size of . Once the device 10 is in the device first configuration (eg, FIG. 1A), the device 10 may be expanded to a size larger than the device first size. For example, the device 10 may be expanded to a size larger than the first size, returned to the device second configuration having a second size (e.g., FIG. can be expanded to sizes between . The device first configuration may be an initial configuration of device 10. The device first form may be a neutral form of the device 10. The second form of the device may be the initial form of the device 10. The second form of the device may be a neutral form of the device 10.

[0128] For example, one hand, two hands, an instrument (e.g., applicator, tab 42), or any combination thereof (also collectively referred to as a dilator) can be moved from the closed state of FIG. 1A to the open state of FIG. 1B. Equipment 10 may be expanded. The dilator may expand the device 10 before it is attached to the substrate 8. Once device 10 is expanded, the same or a different dilator may be used to attach device 10 to substrate 8 while device 10 is in the expanded state. Once the dilator is disconnected or removed from the device 10, the device 10 may be returned (e.g., passive) or returned (e.g., active) to its closed position (e.g., its shape-locked closed position) to remove the target tissue. 6 can be closed. Device 10 may return to a more closed configuration (eg, device first configuration) by force from band 16 alone. Such closure is also called passive closure. As another example, the device may be returned to a more closed configuration by force from band 16 and an external force (eg, from an occluder). Such assisted closure is also referred to as active closure. As yet another example, device 10 may return or be returned to a closed configuration while a dilator is attached to device 10. As yet another example, device 10 may be locked in an expanded state (e.g., partially expanded or fully expanded) after device 10 is expanded (e.g., with an instrument), and the dilator is When removed, device 10 may be allowed to remain in an expanded state. The device 10 may have a closure trigger that can be activated after the device 10 is attached to the substrate 8. When the closure trigger is activated, device 10 may return or be returned to its fixed closed configuration to close the wound. The force of band 16 closing device 10 may close target tissue 6 and maintain device 10 closed. The force that device 10 applies to substrate 8 may be greater than the force that would otherwise hold target tissue 6 open.

[0129] Device 10 may be biased to collapse from the device configuration shown in FIG. 1B to the device configuration shown in FIG. 1A. For example, FIG. 1A shows the device 10 in a relaxed state (also referred to as a neutral state), and FIG. 1B shows the device in a taut state. When device 10 is in a taut state, device 10 may be biased back to a relaxed state. As another example, FIG. 1A shows the device 10 in a taut (eg, contracted) state, and FIG. 1B shows the device 10 in a more taut state compared to the taut state shown in FIG. 1A. When the device 10 is in a more taut state, the device 10 may be biased back to some less taut state, such as the less taut state shown in FIG. 1A.

[0130] As another example, one hand, two hands, an instrument (e.g., applicator, tab 42), or any combination thereof (also collectively referred to as a compressor) may be moved from the open state of FIG. 1B to the open state of FIG. 1A. Device 10 may be retracted to a closed state. The compressor may compress the device 10 before it is attached to the substrate 8. Once the device 10 is deflated, the same or a different compressor may be used to attach the device 10 to the substrate 8 while the device 10 is in the deflated state. Once the compressor is disconnected or removed from the device 10, the device 10 can be returned (e.g., passively) or returned (e.g., actively) to its open position (e.g., its shape-locked closed position). , the target tissue 6 may be released, or the tissue may be pushed towards the target tissue 6. The device 10 may be returned to the open configuration (eg, the device second configuration) by force from the band 16 alone. Such opening is also called passive opening. As another example, the device may be returned to a more open configuration by force from band 16 and an external force (eg, from an occluder). Such assisted closure is also referred to as active closure. As yet another example, device 10 may be returned or returned to an open configuration while a compressor is attached to device 10. As yet another example, device 10 may be locked in a deflated state (e.g., partially deflated or fully deflated) after device 10 is deflated (e.g., by an instrument) and when the compressor is removed. 2, allowing the device 10 to remain in the deflated state. The device 10 may have an opening trigger that can be activated after the device 10 is attached to the substrate 8. When the opening trigger is activated, the device 10 can return or return to its fixed open configuration and open to force tissue toward the target tissue 6. The force of band 16 opening device 10 may release target tissue 6, may push tissue toward target tissue 6, may maintain device 10 open, or any combination thereof. It can be done. The force that device 10 applies to substrate 8 may be greater than the force that would otherwise keep target tissue 6 closed.

[0131] Device 10 may be biased to expand from the device configuration shown in FIG. 1A to the device configuration shown in FIG. 1B. For example, FIG. 1B shows the device 10 in a relaxed state (also referred to as a neutral state), and FIG. 1A shows the device 10 in a tense (eg, contracted) state. When device 10 is in a taut state, device 10 may be biased back to a relaxed state. As another example, FIG. 1B shows the device 10 in a tensioned (e.g., contracted) state, and FIG. 1A shows the device 10 in a more tensioned (e.g., more contracted) state compared to the tensioned state shown in FIG. 1B. A certain device 10 is shown. When the device 10 is in a more taut state, the device 10 may be biased back to any less taut state, such as the less taut state shown in FIG. 1B.

[0132] FIGS. 1A and 1B further illustrate that the target tissue 6 may be a port wound. Port target tissue 6 may have a port size from about 1 cm to about 30 cm or more, including all 1 cm increments within this range. This dimension may be the diameter of the port wound.

[0133] FIGS. 1A and 1B further illustrate that the device 10 may be closed about the central device axis A ₁ . Instrument center axis A ₁ may be the center axis of instrument 10 and may pass through the center of openings 24 and/or 26.

[0134] FIGS. 1A and 1B further illustrate the length of the device 10 along the device longitudinal axis, with or without expansion and/or contraction along the transverse axis perpendicular to the device longitudinal axis. Indicates that the length may be longer and/or the length may be shorter.

[0135] FIGS. 1A and 1B further illustrate that device 10 can be expanded and contracted radially. Expansion and contraction may be symmetrical toward and away from the transverse axis of the device.

[0136] FIGS. 1A and 1B further illustrate that the device 10 may be at the same distance from the edge of the target tissue 6 in the contracted and expanded configurations before the target tissue 6 begins to heal.

[0137] FIGS. 2A and 2B show that the device 10 can be expanded and contracted by the tissue cover 30.

[0138] FIGS. 3A and 3B show that the device 10 can be expanded and deflated by the tissue cover 30 and flaps 32.

[0139] FIGS. 4A and 4B show that device 10 can be expanded and deflated by tissue cover 30, flap 32, and negative pressure wound therapy system 33.

[0140] FIGS. 5A and 5B illustrate that device 10 may expand and/or contract asymmetrically. For example, the device 10 may expand and contract along the device first transverse axis A ₂ rather than along the device second transverse axis A ₃ . As another example, the device 10 may expand and contract along first and second axes A ₂ , A ₃ , but along the second axis A ₃ and along the first axis A ₂ . It is smaller and can expand and contract. As yet another example, the device 10 may expand and contract along first and second axes A ₂ , A ₃ , but along the second axis A ₃ and along the first axis A ₂ . can expand and contract.

[0141] Figures 6A and 6B show that the device 10 can tension and/or compress the substrate 8 with stitches.

[0142] After the device 10 is attached to the substrate 8 in an expanded configuration (e.g., a fully expanded state), the device 10 may extend or not extend across the target tissue 6 to close the target tissue 6. . Openings 24 and 26 may remain unobstructed during attachment of device 10 to a substrate and/or while device 10 is retracted while attached to a substrate. However, FIG. 6A shows that tensioner 28 may extend across openings 24 and 26 before, during, and after deflation.

[0143] FIGS. 7A and 7B show that the device 10 can be attached to a non-flat substrate 8. For example, device 10 may be attached to curved substrate 8. The base material 8 may have a convex curved surface, a concave curved surface, or both. Device 10 may be attached to a substrate having the radius of curvature of any body part. For example, device 10 may be attached to the user's head, face (e.g., forehead, cheeks, nose, chin), neck, back, chest, arms, wrists, hands, fingers, legs, ankles, feet, and/or toes. It can be done. Device 10 may be attached to a single body part. Device 10 may be attached to multiple body parts at the same time, such as the user's cheek and chin.

[0144] FIGS. 7C and 7D show that the device 10 can be attached to a flat substrate 8.

[0145] FIG. 8 shows that the device 10 can be attached to the substrate 8 and removed therefrom using the tabs 42.

[0146] Device 10 may be controllably adjusted (eg, expanded and/or deflated). For example, the state of device 10 may be changed incrementally, eg, as measured in terms of maximum expansion and/or contraction percentages. For example, the device 10 may be expanded in increments of about 5% to about 25%, with increments of 5% within this range (e.g., 0% expansion, 25% expansion, 50% expansion, 75% expansion, 100% expansion). Such incremental value adjustments may be made over a duration of 10 seconds or more, a day or more, or a week or more.

[0147] Device 10 may tension tissue adjacent the skin graft. Device 10 may compress tissue adjacent the skin graft. Device 10 may tension and compress tissue adjacent the skin graft. This may desirably provide a skin graft with a more stable growth surface.

[0148] Device 10 may tension tissue with stitches. Device 10 may compress tissue with stitches. The device 10 may tension and compress tissue with stitches. This can desirably help stabilize the tissue near the stitch, which in turn can reduce distortion of both the stitch and the surrounding skin. With less strain, thinner sutures and/or fewer sutures passing through the tissue may be used.

[0149] The device 10 may automatically return to the neutral position when released from the non-neutral position. When the device 10 is released from a non-neutral position (e.g., a fixed shape state, an expanded state, a contracted state, or any combination thereof), it may be manually returned to a neutral position.

[0150] Large, intermediate, and/or small devices 10 may be sequentially placed on the substrate 8 to regulate the growth of new tissue during the healing process.

[0151] Device 10 may release antibiotics, nutrients, or both to target tissue 6. For example, coverings and/or wound dressings with antibiotics and/or nutrients may release them over time or all at once to the target tissue 6. As another example, the cover and/or wound dressing may be or include one or more patches, such as iotophoreas patches, electroporation patches, or both.

[0152] Figures 9A-9E can be used, for example, to close a wound, to close a lesion, to relieve tissue tension in the target tissue 6 (eg, a pustule), or any of the following. It is shown that for combination, the device 10 can be placed partially or completely around the target tissue 6. Once or after the device 10 is placed around the target tissue 6, the device 10 can be removed from, e.g., a larger form (e.g., the second form of the device in FIG. 9A) to close the target tissue 6. The size may be reduced and/or reduced by moving to a smaller configuration (eg, the device first configuration of FIG. 9B). As another example, once or after the device 10 is placed around the target tissue 6, the device 10 may be used to force (e.g. push) the skin and/or underlying tissue towards the target tissue 6, e.g. By moving from a large configuration (e.g., the device second configuration of FIG. 9A) to a smaller configuration (e.g., the device first configuration of FIG. 9B), the device 10 can be reduced in size and/or reduced in size. It is possible. The target tissue may be one or more pustules (eg, acne). For example, FIGS. 9A and 9B show that device 10 can be attached to tissue so that it can completely surround three pustules. However, the device 10 may be attached to tissue having from 1 to 50 or more pustules, including all increments of 1 pustule incision within this range. FIG. 9A shows the device 10 in a taut state, and FIG. 9B shows the device in a relaxed state (also referred to as a neutral state). As another example, FIG. 9A shows the device 10 in a taut condition, and FIG. 9B shows the device in a less taut condition compared to the condition shown in FIG. 9A.

[0153] FIGS. 9A and 9B further illustrate that the size of the pustule may decrease when the device 10 is deflated from the taut state of FIG. 9A to the relaxed or less taut state of FIG. 9B. . For example, the target tissue 6 (e.g., a pustule) may have a first size 6 _A1 before the device 10 is deflated, and less than the first size 6 _A1 after the device 10 is deflated. It may have a smaller second size 6 _A2 . The first and second sizes 6 _A1 , 6 _A2 are measurable characteristics of the target tissue 6, such as length, width, height, surface area, skin thickness, circumference (e.g. circumference) of the target tissue 6. , or any combination thereof. For example, FIGS. 9A and 9B show that the device 10 can be placed on or over the target tissue 6, which can pull the skin and underlying tissue toward the target tissue 6 (e.g., radially) and reduce the elongation of the target tissue 6. Indicates that the pressure in the vicinity can be reduced, or both. In this manner, the device 10 is placed over the target tissue 6 (e.g., a lesion or pustule) and compresses, pushes and/or pulls healthy skin towards the target tissue 6, thereby , the skin overlying the target tissue 6 may be rendered taut.

[0154] FIGS. 9A and 9B further illustrate that the skin may have wrinkles 46. The wrinkles 46 may be, for example, wrinkles in the stratum corneum, stratum lucidum, stratum granulosum, stratum spinosum, stratum basale, stratum dermis, or any combination thereof of the skin. 9A and 9B show that some of the wrinkles 46 decrease in size when the device 10 is contracted from the relaxed or taut state of FIG. 9B to a more relaxed state (e.g., from the taut state of FIG. 9A). the size of some of the wrinkles 46 may increase (e.g., deepen); one or more new wrinkles 46 may form in the skin; It shows that folds 48 (also referred to as over-wrinkling) may be formed in the skin, new skin features 50 may be formed in the skin, or any combination thereof. New skin features 50 may be, for example, skin wrinkles, skin folds, or both. For example, FIGS. 9A and 9B show that wrinkles 46 on the outside of the device 10 (e.g., not within the openings 24, 26) can flatten when the device 10 is retracted (e.g., when the device 10 stretches the skin). ), the folds 46 near or within the target tissue 6 may become deep (e.g., when the device 10 compresses skin that is within the openings 24 and 26, for example); new skin features may be formed in or near the target tissue 6 (e.g., if device 10 compresses the skin); ), or any combination thereof. As an example, the wrinkles 46 on the outside of the device 10 in FIG. 9A are shown stretched and are not visible in FIG. 9B. 9A and 9B illustrate that the device 10 can tension and detension tissue. Where the device 10 tensions or stretches the tissue, skin wrinkles and/or folds 46, 48 may stretch, become smaller, shallower, and/or wider, become less visible, or disappear completely. or any combination thereof. Some or all of the wrinkles and folds 46, 48 may return to the skin or otherwise become visible again when the pulling force applied to the skin by the device 10 is released or reduced. . For example, wrinkles that are elongated on the outside of the device 10 when the device 10 is in the retracted configuration (e.g., the retracted configuration of FIG. 9B) may be removed, e.g., by removing the device 10 from the skin, When the pulling force is released or reduced by changing the configuration (e.g., by changing the device 10 from the contracted configuration of FIG. 9B to the non-contracted configuration of FIG. 9A), it de-extends and becomes visible again. obtain. Where the device 10 detension or compress tissue, the wrinkles and/or folds 46, 48 in the skin may become clustered, larger, deeper, and/or narrower, and more visible. , new wrinkles and folds may be formed, or any combination thereof. Some or all of the wrinkles and folds 46, 48 may return to the skin or otherwise become visible again when the compressive force applied to the skin by the device 10 is released or reduced. For example, when the device 10 was in the retracted configuration (e.g., the retracted configuration of FIG. 9B) or by changing the device 10 to a less contracted configuration (e.g., by changing the device 10 from the contracted configuration of FIG. 9B). When the compressive force is released or reduced (by changing to the uncontracted configuration of FIG. 9A), it can de-extend and become visible again. Thereby, FIGS. 9A and 9B illustrate the skin being compressed (also referred to as crushed) inside the device 10 (e.g., within the openings 24, 26), and the skin being outside the device 10 (e.g., within the openings 24, 26). outside the openings 24, 26), showing the skin being stretched.

[0155] FIGS. 9A and 9B-1 show that the size of the pustules remains the same as the device 10 contracts from the taut state of FIG. 9A to the relaxed or less taut state of FIG. 9B-1. Show what you get. For example, FIGS. 9A and 9B show that the target tissue 6 (eg, a pustule) can have a first size 6 _A1 in both the pre-systolic and post-systolic forms.

[0156] FIGS. 9C and 9D show one of the pustules inside the device 10. FIG. 9C shows that the target tissue 6 (e.g., the skin and underlying tissue near the pustule) cannot be stretched further in FIG. 9D than in FIG. 9C; by the size of the wrinkles 46 being larger, deeper and/or narrower than in FIG. 9C, by the wrinkles 46 being more clearly visible in FIG. 9D than in FIG. 9C, by the appearance of new wrinkles and/or folds in FIG. or any combination thereof. 9C and 9D further show that the target tissue 6 may extend away from the surface of the surrounding skin to a target tissue height _6H , for example due to inflammation in the target tissue 6. The surrounding skin may be part of the target tissue 6 or may be different from (eg, adjacent to) the target tissue 6. The target tissue height _6H is the same when the device 10 is in the non-deflated state (e.g., before the device 10 is deflated) and when the device is in the retracted state (e.g., after the device 10 is deflated). may be or may be different. By placing the target tissue 6 in a tense and/or detonated state, the device 10 changes from the device non-contracted configuration to the device 10 when the device changes from the first configuration to the second configuration or vice versa. The target tissue height _6H can be increased, maintained, or decreased to the contracted configuration, or vice versa. Compression of tissue due to device 10 within the target area may decrease target tissue height _6H , increase target tissue height _6H , or both. For example, FIGS. 9C and 9D further illustrate that before device deflation, target tissue 6 may have a target tissue first height _6H1 , and that after device deflation, target tissue 6 may have a target tissue first height 6H1. The target tissue may have a second height _H2 equal to, greater than, or less than _H1 (may depend on the reference point chosen to establish the base of the measured height). ) is shown. For example, the base may be selected to be a fixed radial distance away from the center of the target tissue 6, or may be selected to be measured from where the skin is flat with respect to the target tissue 6.

[0157] Figure 9E shows a solution 45 (eg, therapeutic ointment) applied to the top of the target tissue 6 (eg, pustule, lesion). Skin desensitization may enhance local absorption of solution 45 at and/or near target tissue 6. As another example, the solution 45 or drug may not be used and the detonated state alone may have beneficial healing effects, for example, by reducing scarring, increasing healing rates, or both. can bring about

[0158] FIGS. 9A to 9E further illustrate that the device 10 is in the device treatment configuration (eg, device retracted configuration, device first configuration) and in the device pre-treatment configuration (eg, device expanded configuration, device second configuration). This indicates that it may be closer to the target tissue 6 than the target tissue 6. For example, FIGS. 9A-9E show that one or more of the engagers 12, one or more of the mounts 14, the bands 16, or any combination thereof are in a device treatment configuration (e.g., device retracted configuration, device first configuration). may be closer to the target tissue 6 than in the device pre-treatment configuration (e.g. device extended configuration, device second configuration).

[0159] FIGS. 10A-10E can be used, for example, to close a wound, to close a lesion, to relieve tissue tension in a target tissue 6 (eg, a pustule), or any of the following. It is shown that for combination, the device 10 can be placed next to the target tissue 6. When the device 10 is placed next to the target tissue 6, the device 10 can move from, for example, a smaller configuration (e.g., the device first configuration of FIG. 10A) to a larger configuration (e.g., the device second configuration of FIG. 10B). ) by increasing the size and/or increasing the size and pushing the tissue towards the target tissue 6 so that the wound can be closed or the pressure applied to the target tissue 6 can be reduced. obtain. As another example, once or after the device 10 is placed next to the target tissue 6, for example, from a smaller form (e.g., the device first form of FIG. 10A) to a larger form (e.g., the device first form of FIG. 10B) (second form of the device), the device 10 is increased in size and/or increased in size and may force (eg, push) the skin and/or underlying tissue toward the target tissue 6 . The target tissue may be one or more pustules (eg, acne). For example, FIGS. 10A and 10B show that device 10 can be attached to tissue so that it can be next to or partially surround three pustules. However, the device 10 may be mounted next to tissue having from 1 to 50 or more pustules (including all increments of 1 pustule incision within this range). FIG. 10A shows the device 10 in a relaxed state, and FIG. 10B shows the device in a relaxed state (also referred to as a neutral state). As another example, FIG. 10A shows the device 10 in a taut condition, and FIG. 10B shows the device in a less taut condition compared to the condition shown in FIG. 10A.

[0160] FIGS. 10A and 10B further illustrate that the size of the pustule may decrease as the device 10 expands from the taut state of FIG. 10A to the relaxed state of FIG. 10B or the less taut state. . For example, the target tissue 6 (e.g., a pustule) may have a first size 6 _A1 before the device 10 is expanded, and a second size smaller than the first size 6 _A1 after the device 10 is expanded. 2 size 6 _A2 . The first and second sizes 6 _A1 , 6 _A2 are measurable characteristics of the target tissue 6, such as length, width, height, surface area, skin thickness, circumference (e.g. circumference) of the target tissue 6. , or any combination thereof. For example, FIGS. 10A and 10B show that the device 10 is directed towards the target tissue 6 to reduce the stretch of the target tissue 6, to reduce the pressure on or near the target tissue 6, or both. Indicates that the tissue can be pushed (eg, pushed radially). In this way, the device 10 is placed near (eg, not over) the target tissue 6 (eg, a lesion or pustule) to compress or push healthy skin toward the target tissue 6. 2, thereby causing the skin overlying the target tissue 6 to become taut. 10A and 10B further show that the skin may have wrinkles 46. The wrinkles 46 may be, for example, wrinkles in the stratum corneum, stratum lucidum, stratum granulosum, stratum spinosum, stratum basale, stratum dermis, or any combination thereof of the skin. 10A and 10B show that the size of some of the wrinkles 46 changes as the device 10 is expanded (e.g., from the taut state of FIG. 10A) to a relaxed state or from the taut state of FIG. 10B to a more relaxed state. the size of some of the wrinkles 46 may increase (eg, become deeper); one or more new wrinkles 46 may form in the skin; one or more folds 48 (also referred to as excessive wrinkles) may be formed in the skin, new skin features 50 may be formed in the skin, or any combination thereof. New skin features 50 may be, for example, skin wrinkles, skin folds, or both. For example, FIGS. 10A and 10B show that the wrinkles 46 on the inside of the device 10 (e.g., within the openings 24, 26) may flatten when the device 10 is expanded (e.g., when the device 10 stretches the skin); The wrinkles 46 near or within the target tissue 6 may deepen (e.g., when the device 10 compresses the skin), and the folds 48 may form in the skin near or within the target tissue 6 (e.g., when the device 10 compresses the skin). (e.g., when the device 10 compresses the skin), new skin features may be formed in or near the target tissue 6 (e.g., when the device 10 compresses the skin), or any combination thereof. As an example, the wrinkles 46 on the inside of the device 10 in FIG. 10A are shown stretched and are not visible in FIG. 10B. FIGS. 10A and 10B illustrate that device 10 can cause tissue to become taut and detonic. Where the device 10 tensions or stretches the tissue, the wrinkles and/or folds 46, 48 in the skin may elongate, become smaller, shallower, and/or wider, become less visible, or completely disappear. or any combination thereof. Some or all of the wrinkles and folds 46, 48 may return to the skin or otherwise become visible again when the pulling force applied to the skin by the device 10 is released or reduced. For example, wrinkles that are elongated inside the device 10 when the device 10 is in the expanded configuration (e.g., the expanded configuration of FIG. 10B) can be removed by, for example, removing the device 10 from the skin or by making the device 10 less expanded. When the tensile force is released or reduced (e.g., by changing the device 10 from the expanded configuration of FIG. 10B to the unexpanded configuration of FIG. 10A), it de-extends and becomes visible again. It can become like that. Where the device 10 detension or compress the tissue, the wrinkles and/or folds 46, 48 within the skin may cluster together, become larger, deeper, and/or narrower, and become more visible. new wrinkles and folds may be formed, or any combination thereof. Some or all of the wrinkles and folds 46, 48 may return to the skin or otherwise become visible again when the compressive force applied to the skin by the device 10 is released or reduced. For example, when the device 10 was in the expanded configuration (e.g., the expanded configuration of FIG. 10B), the wrinkles that were on the outside of the device 10 but in a taut state (e.g., the wrinkles could be e.g. the crests or peaks of skin folds). 10B), or by changing the device 10 to a less expanded configuration (e.g., changing the device 10 to the expanded configuration of FIG. 10B). When the compressive force is released or reduced (by changing from the non-expanded configuration of FIG. 10A), it can de-extend and become visible again. Thereby, FIGS. 10A and 10B show compressed (also referred to as crushed) skin on the outside of the device 10 (e.g., outside the openings 24, 26) and on the inside of the device 10 (e.g., outside the openings 24, 26). 24, 26) showing the stretched skin.

[0161] FIGS. 10A and 10B-1 show that the size of the pustules remains the same even as the device 10 expands from the taut state of FIG. 10A to the relaxed state of FIG. 10B-1 or the taut state to a more relaxed state. Show that it can be done. For example, FIGS. 10A and 10B show that the target tissue 6 (eg, a pustule) can have a first size 6 _A1 in both the pre-expanded and post-expanded configurations.

[0162] FIGS. 10C and 10D show one of the pustules on the outside of the device 10. FIG. 9C shows that the target tissue 6 (e.g., the skin and underlying tissue near the pustule) cannot be stretched any further in FIG. 10D than in FIG. 10C; The appearance of new wrinkles and/or folds in FIG. 10D that are not present in FIG. 10C, due to the size of the wrinkles 46 being larger, deeper, and/or narrower than in FIG. or any combination thereof.

[0163] FIG. 10E shows a solution 45 (eg, therapeutic ointment) applied to the top of the target tissue 6 (eg, pustule, lesion). The detonated state of the skin may enhance local absorption of the solution 45 at and/or near the target tissue 6. As another example, the solution 45 or drug may not be used and the detonated state alone produces a beneficial healing effect, e.g., by reducing scarring, increasing healing rates, or both. obtain.

[0164] The device 10 may treat lesions or pustules, such as acne on the torso (eg, acne on the back). Device 10 may treat lesions such as acne or pustules on a person's face. The device 10 treats the lesion or pustule by pushing and/or pulling tissue toward the lesion or pustule to cause the skin overlying the lesion or pustule to be stretched or detensioned. It is possible. Reducing the amount that the skin over and/or near the lesion or pustule is stretched and taut may advantageously reduce or prevent scarring, and topical medicinal solutions may advantageously reduce or prevent scarring. (eg solution 45) may be enhanced.

[0165] FIGS. 10A to 10E further illustrate that device 10 is in a device treatment configuration (eg, device expanded configuration, device second configuration) and in a device pre-treatment configuration (eg, device retracted configuration, device first configuration). This indicates that it may be closer to the target tissue 6 than the target tissue 6. For example, FIGS. 10A-10E show that one or more of the engagers 12, one or more of the mounts 14, the bands 16, or any combination thereof are in a device treatment configuration (e.g., device retracted configuration, device first configuration). may be closer to the target tissue 6 than in the device pre-treatment configuration (e.g. device extended configuration, device second configuration).

[0166] Solution 45 may include one or more natural and/or artificial tissue treatment agents, drugs (e.g., anti-inflammatory agents, local anesthetics), antibiotics, nutrients, or any combination thereof. . Solution 45 may have any of the properties of any of the solutions described, illustrated and/or discussed elsewhere in this application. Device 10 may apply solution 45 to target tissue 6, for example, every 1 to 24 hours (including all hourly increments within this range).

[0167] As another example, device 10 may not have a neutral configuration such that device 10 is balanced and unbiased in either device configuration. In such variations, device 10 may be manually expanded and/or deflated to achieve the functions and results described in this application with respect to substrate 8 and target tissue 6.

[0168] As yet another example, the device 10 - with or without an internal spring - can be manually expanded and/or deflated against the substrate 8 and target tissue 6 to perform the functions and results described in this application. can be achieved. For example, band 16 may be biased or unbiased, such that band 16 may be spring or non-spring. If band 16 is not a spring, device 10 may be manually manipulated using an instrument (e.g., applicator, tab 42), one hand, two hands, or any combination thereof to increase and/or decrease the size of the device. may cause the skin and/or underlying tissue to move correspondingly and affect the target tissue 6 as desired (e.g., open a wound, close a wound, reduce pressure on or near a pustule). (reducing the amount by which the skin above or near the pustule is stretched).

[0169] Device 10 may be worn during the treatment period. The treatment period is, for example, 5 minutes to 15 minutes, 5 minutes to 60 minutes, 1 hour to 24 hours, 1 hour to 2 days or more, 1 day to 7 days or more, 1 day to 30 days or more, less than 90 days, 30 days. It can range from less than 1 day to less than 7 days to less than 1 day, and includes all 1 minute, 1 hour, and 1 day increments within these ranges. A user may wear the device while awake, while sleeping, or both.

[0170] Although the drawings (eg, FIGS. 9A-10E) show target tissue 6 being elevated relative to surrounding tissue, for example due to local inflammation, target tissue 6 is elevated; It may be unraised (eg, flat, recessed), or both. As another example, at tissue sites where device 10 compresses tissue, this may bring the tissue together. As yet another example, at a tissue site where device 10 places tissue under tension, this may cause the tissue to stretch, flatten, or both.

[0171] The device 10 may be removably engaged to a user with or without penetrating the user's skin.

[0172] In this specification, US Pat. No. 7,455,681; US Pat. No. 7,799,042; US Pat. , 640; and 9,179,914 are incorporated by reference in their entirety for all purposes. The disclosures in these patents and this disclosure may be combined and modified with each other in any combination. For example, device 10 may have any of the features of the devices in these patents. As another example, the methods disclosed herein may include any of the steps and/or apparatus for practicing the methods in these patents.

[0173] The specific variations described herein are provided for purposes of illustration only. The above-described variations, forms, features, elements, methods, and variations of these aspects may be combined and modified with each other in any combination. Any element described herein as singular may be made plural (i.e., anything described as "one" may represent two or more). Any species member of a genus member may have the characteristics or elements of any other species member of that genus.

Claims (20)

A tissue care device that:
a plurality of tissue engagers capable of attaching the device to a substrate having target tissue ;
a plurality of mounts coupled to each of the plurality of tissue engagers; and a closed loop retractable band coupled to each of the plurality of mounts, the closed loop forming a plurality of corners and a respective branch between the corners. the band having a shape including a part;
A tissue care device, wherein each of the plurality of mounts is attached to each of a number of the respective branches. The tissue care device of claim 1, wherein the collapsible band is expandable. The tissue care device of claim 1, wherein the retractable band is removable with respect to the plurality of mounts . The tissue care device of claim 1, wherein the collapsible band defines a device opening. 5. The tissue care device of claim 4, wherein the device opening provides access to target tissue. The tissue care device of claim 1, wherein the device is attachable to tissue. 2. The tissue care device of claim 1, wherein the device has a first device configuration and a second device configuration that is larger than the first device configuration. 8. The tissue care device of claim 7, wherein the device is expandable from the device first configuration to the device second configuration. 9. The tissue care device of claim 8, wherein the device is collapsible from the device second configuration to the device first configuration. 10. The tissue care device of claim 9, wherein the device is collapsible from the second device configuration to a third device configuration that is smaller than the first device configuration. A tissue care device that:
a plurality of tissue engagers capable of attaching the device to a substrate having target tissue ; and a closed loop retractable band coupled to each of the plurality of tissue engagers, the closed loop having a plurality of corners and corners. said band having a shape comprising respective branches between ;
A tissue care device, wherein each of the plurality of tissue engagers is attached to each of the arbitrary number of branch sections of the respective branch sections. 12. The tissue care device of claim 11, wherein the device has a device first configuration and a device second configuration that is larger than the device first configuration. 13. The retractable band is in a neutral configuration when the device is in the device first configuration and in a non-neutral configuration when the device is in the device second configuration. tissue care equipment. the collapsible band includes a shape memory alloy; and the collapsible band is in a shape-fixed configuration when the device is in the device first configuration; and the collapsible band is in a shape-fixed configuration when the device is in the device second configuration. 13. The tissue care device of claim 12, wherein the tissue care device is in a distorted configuration departing from the fixed shape configuration. 12. The tissue care device of claim 11, wherein when the device is attached to tissue, the device is configured to automatically close target tissue by contraction of the collapsible band. 12. The tissue care device of claim 11, wherein the retractable band is a toroid. The tissue care device of claim 1, wherein the collapsible band has a bulge at the branch. The tissue care device according to claim 17, wherein the bulge is provided outside a position where the band and the mount are attached. 12. The tissue care device of claim 11, wherein the collapsible band has a bulge at the branch. The tissue care device according to claim 19, wherein the bulge is provided outside a position where the band and the tissue engager are attached.

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